RBM Gets Gritty

By Penny Manasco - August 2, 2016

Our team just finished reading Grit, an instant New York Times bestseller, by Angela Duckworth. We loved the book. Its messages will resonate with everyone now in the process of adopting, implementing, and/or managing the principles of Risk Based Monitoring (RBM).

Duckworth describes Grit (Passion + Perseverance) as the best predictor of success. Beyond talent, beyond intelligence, beyond scores on other aptitude tests—Grit predicted who would advance farther in the National Spelling Bee and who would succeed at West Point.

Grit determines who will see setbacks as opportunities to learn and improve and who will see setbacks as failures. Grit also describes people who see their job as more than a job—as a higher calling.

So how does that apply to adopting RBM?

Let’s take Passion. One could consider adopting Risk-Based Monitoring as something that has to be done based on the new FDA, EMA, and ICH GCP Guidelines. Alternatively, it is passion that drives one to see adopting RBM as our pledge to every study participant, who gives so generously to participate in clinical trials, to assure their participation leads to important scientific answers while protecting their rights and safety.

Now let’s look at Perseverance. While many people talk about RBM generically, the ones actually adopting, implementing, and managing RBM talk about its iterative evolution. We learn from every trial and continually adopt methods to better conduct trial oversight. RBM is not just fewer monitoring visits, it’s the systematic review of operational and clinical data to ensure the best quality possible.

Take the first step in RBM and Total Quality Management: Risk Assessment. We just completed the first step of Risk Assessment with a study team. By having everyone working on the study in the same room discussing what could go wrong, each functional team member (Clinical Scientist, Medical Monitor, Clinical Operations, Data Management, and Investigational Product Management) provided their unique perspective and experience. Our approach to data collection, process design, and oversight changed based on that input. By understanding what could go wrong, we can build the tools to minimize the risk and improve our study oversight.

Why do I think you need Grit to adopt RBM? Because you will have to change your thinking, your processes, your technology tools, your outsourcing models, and your colleagues’ minds who abhor change and don’t want to move from their old “SDV has worked for years” to the new RBM methodology.